Harbour BioMed and Utrecht University Announce Licensing Agreement with AbbVie for COVID-19 Antibody and Initiation of Clinical Trial
Harbour BioMed
Antibody Drug Developer
Utrecht University
Utrecht University is a public research university located in Utrecht, the Netherlands. Founded on March 26, 1636 (384 years ago), it is one of the oldest universities in the Netherlands as of 2018. The university’s mission is to provide education in science and various other fields; conduct scientific and multidisciplinary research; and serve society. Utrecht University comprises seven faculties. Apart from technical and agricultural engineering programs offered by universities of applied sciences, Utrecht University offers courses in nearly all fields of knowledge, making it the largest university in the Netherlands. It offers 45 bachelor’s programs, 138 master’s programs, and 32 teacher training programs. Among these, 6 bachelor’s and 89 master’s programs are taught in English, covering almost all academic disciplines.
AbbVie
Innovative Drug Developer
Cambridge, Massachusetts、Suzhou, China and Utrecht, the Netherlands, December 15, 2020 /PRNewswire/ -- Harbour BioMed (Stock Code: 02142.HK), a global biopharmaceutical company with candidates in clinical development, and Utrecht University jointly announced today that ABBV-47D11, a fully human neutralizing antibody against COVID-19 and related coronaviruses for prevention and treatment, licensed to AbbVie, has entered Phase I clinical trials. AbbVie will initially conduct this clinical study in the United States and expand it to Europe.
Harbour BioMed’s H2L2 fully human transgenic mouse platform enables the rapid discovery and development of potent drug candidates, with ABBV-47D11 emerging as the ideal candidate for this program due to its cross-reactive neutralizing properties. This antibody targets a conserved region of SARS-CoV-2, and collaborative preclinical studies to date have demonstrated that antibodies against this target exhibit strong therapeutic potential against the current pandemic, including activity against a range of potential escape mutations.
The signing of this license agreement will help facilitate the development of ABBV-47D11. In preclinical studies, the antibody demonstrated the potential to block infection by both SARS-CoV-2 and SARS-CoV-1. Under the in-licensing agreement, AbbVie will be responsible for the clinical development of ABBV-47D11 and, pending successful clinical outcomes, will oversee its global manufacturing and commercialization. AbbVie will pay Harbour BioMed and Utrecht University an upfront equity transfer fee, as well as milestone payments tied to development, regulatory approvals, and sales, along with tiered royalties based on net commercial sales. Erasmus University Medical Center participated in the foundational scientific research but is not a party to the licensing agreement. Other terms were not disclosed.
The Phase I clinical trial will be a randomized, double-blind, placebo-controlled study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-47D11 during single ascending dose escalation in adult hospitalized patients with COVID-19. The trial will enroll 24 patients across multiple global research sites, stratified into three dose groups. The primary endpoint is the assessment of study drug-related adverse events, with multiple secondary endpoints established. For further details on the trial, pleaseClick here
Dr. Wang Jinsong, Principal Founder, Executive Director, Chairman of the Board, and Chief Executive Officer of Harbour BioMed, stated: “The rapid progress achieved in this project relies on our outstanding R&D team, our collaboration with university partners, the strengths of Harbour BioMed’s fully human antibody discovery platform, and AbbVie’s globally leading expertise in the development of antibodies and antiviral therapeutics. As clinical trials for this project commence, we hope to provide a new treatment option for the current pandemic.”